API Regulatory Affairs
16 hours ago
Role - API Regulatory Affairs - DMF Filing/ Compilation (Global market)
Level - Associate Manager / Manager Level:-
Required Education/Exp :-
Experience Req.: 11 yrs. - 18 yrs.
Qualification: - M.Sc. / M.Pharma
Responsibilities
1. Hands on Regulatory Affairs-API /DMF Filing/ DMF Compilation/ Submission/ Customer Communication etc.
2. Compilation and submission of DMFs globally for small molecule APIs in eCTD format and in-line with ICH and region specific (EU, US, Canada, Japan, Australia, Brazil, China, South Korea etc.) regulatory guidelines.
3. Should have good knowledge of all the regulatory guidelines and API Regulatory processes.
4. Compilation of response to queries received from Regulatory Agencies & customers globally and submission of response within the stipulated timeline.
5. Review and submission of new DMFs, deficiency responses, amendments, updations to various regulatory agencies.
6. Evaluation of change controls and updating to agencies by considering change categories.
7. Should have hands-on experience in eCTD software
Candidates with relevant exp., kindly share CVs to apply on :-
Kindly mention below details while sharing CV :-
- Total Exp?
- Current CTC?
- Total number of DMF filings?
- Handling which major markets globally ?
- Notice Period?
- Ready to work in Bangalore (onsite) ? (5 Days working)
-
API Regulatory Affairs
13 hours ago
Bengaluru, Karnataka, India Biocon Ltd Full time ₹ 15,00,000 - ₹ 20,00,000 per yearRoleAPI Regulatory Affairs DMF Filing/ Compilation (Global market)Level Associate Manager / Manager Level:-Required Education/Exp :-Experience Req. : 11 yrs.18 yrs. Qualification:M.Sc. / M.PharmaResponsibilities1. Hands on Regulatory Affairs-API /DMF Filing/ DMF Compilation/ Submission/ Customer Communication etc.2. Compilation and submission of DMFs...
-
Regulatory Affair Manager
4 weeks ago
Bengaluru, Karnataka, India Natural Biogenex Pvt Ltd Full timeNote: The selected candidate must be willing to visit the manufacturing facility in Vasanthanarsapura, Tumkur at least two days a week and/or as required based on operational and regulatory needs.Job Title: Regulatory Affairs ManagerLocation: Jayanagar 2nd block, Bengaluru/Vasanthnarasapura KIADB Industrial Area, Tumkur, KarnatakaExperience: 12 - 15 years...
-
Regulatory Affair Manager
4 weeks ago
Bengaluru, Karnataka, India Natural Biogenex Pvt Ltd Full timeNote: The selected candidate must be willing to visit the manufacturing facility in Vasanthanarsapura, Tumkur at least two days a week and/or as required based on operational and regulatory needs.Job Title: Regulatory Affairs ManagerLocation: Jayanagar 2nd block, Bengaluru/Vasanthnarasapura KIADB Industrial Area, Tumkur, KarnatakaExperience: 12 - 15 years...
-
Regulatory Affairs Specialist
5 days ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000Regulatory Affairs SpecialistThis role is a great opportunity for individuals with a strong understanding of regulatory affairs and a passion for ensuring compliance. The Regulatory Affairs Specialist will play a critical role in assisting international regulatory teams with navigating evolving business needs in the Indian market.Key...
-
Regulatory Affair Manager
4 weeks ago
Bengaluru, Karnataka, India Natural Biogenex Pvt Ltd Full timeJob DescriptionNote: The selected candidate must be willing to visit the manufacturing facility in Vasanthanarsapura, Tumkur at least two days a week and/or as required based on operational and regulatory needs.Job Title: Regulatory Affairs ManagerLocation: Jayanagar 2nd block, Bengaluru/Vasanthnarasapura KIADB Industrial Area, Tumkur, KarnatakaExperience:...
-
Regulatory Affairs Specialist
1 week ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000Job Title: Regulatory Affairs Specialist">Job Description:">We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to manage and support regulatory submissions, ensure compliance with global regulatory requirements, and maintain the highest standards of operational excellence in regulatory processes.">Technical skills: Deep...
-
Regulatory Affairs Expert
3 days ago
Bengaluru, Karnataka, India beBeeExcellence Full time ₹ 90,00,000 - ₹ 1,20,00,000Unlock Regulatory ExcellenceJob Description:As a Regulatory Affairs Specialist, you will play a vital role in ensuring the compliance of our solutions in Healthcare, Life Science, and Electronics. You will work closely with cross-functional teams to define regional regulatory strategies for product changes and serve as an internal point of contact for TA and...
-
Regulatory Affairs Professional
1 week ago
Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 8,46,992 - ₹ 12,99,898Regulatory Affairs AssociateThis is a critical role that involves providing regulatory support to various departments across the organization. The successful candidate will be responsible for ensuring that all regulatory activities align with business needs.Key Responsibilities:The Regulatory Affairs Associate will be responsible for:Providing regulatory...
-
Regulatory Affairs Professional
3 days ago
Bengaluru, Karnataka, India beBeeRegulatory Full timeRegulatory Affairs ProfessionalThe ideal candidate will be responsible for working closely with international regulatory teams to ensure compliance with Indian regulations.Develop and maintain in-depth knowledge of India's Medical Device Regulations (MDR).Collaborate with cross-functional teams to implement effective regulatory strategies.Identify and...
-
Regulatory Affairs Specialist
6 days ago
Bengaluru, Karnataka, India Biocon Biologics Full timePosition SummaryThe Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in...